Details

Introduction

The programme will cover the regulatory landscape, the definition and classification of ATMPs and provide practical guidance on how to overcome quality and specific GMP challenges. Comparison of the differences between GMP for Advance Medicinal Therapeutic Product (ATMPs) and conventional therapeutics will be discussed. Consideration of what is required for clinical trials and the preparation of the IMPD will also be addressed. Furthermore advice on the specific transportation requirements of these products will be included.

This seminar will be of benefit to all those involved with or considering developing an Advance Medicinal Therapeutic Product.

Who should attend

R & D personnel involved in research on cell or gene based therapies

Managers involved in the development and manufacture of ATMPs

Quality assurance and quality control personnel responsible for quality aspects of ATMPs

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